Bifocal Contact Lens Study for Adults With Age-Related Near Vision Loss

Clerio Vision Inc. has licensed a new femtosecond based laser procedure discovered by
researchers at the University of Rochester known as Laser Induced Refractive Index
Customization (LIRIC), which allows the alteration of the optical design of a finished soft
hydrogel contact lens. Clerio Vision Inc. scientists have developed a diffractive multifocal
optical design using the LIRIC procedure which shows an increase of the depth of focus of the
contact lens when measured on an optical bench. It is hypothesized that a presbyopic patient
wearing a soft contact lens of this design will experience an improvement in intermediate and
near vision over that provided by their distance corrected single vision contact lenses,
without significantly impacting their distance vision. The purpose of this feasibility study
is the on-eye evaluation of the performance of the Clerio Vision designed and LIRIC modified
soft contact lenses. Results from this study will guide future development of these potential
products.

Inclusion Criteria:

- Legal age (at least 21) on the date the Informed Consent Form (ICF) is signed and have
the capacity to provide voluntary informed consent

- Able to read, understand and provide written informed consent on the Institutional
Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as
appropriate for local privacy regulations.

- Willing and able to comply with all study instructions/procedures.

- Best Distance Spherical Corrected Visual Acuity (BDSCVA) in at least one eye of 20/25
(0.10 logMAR).

- Physiologically normal anterior segments not exhibiting clinically significant
biomicroscopy findings.

- Previous experience with contact lenses.

- Distance spectacle spherical correction in at least one eye within +/- 5D of the study
lens power (-3.00D).

- Habitual spectacle addition (at 40cm) of at least +1.00D.

- Refractive astigmatism less than -2.75D.

- Most recent complete eye examination was within the last 24 months of the date of
study completion.

Exclusion Criteria:

- Currently participating in any drug or device clinical investigation during the period
of study participation.

- Active anterior segment ocular disease or using any ocular medication for anterior
segment disease (e.g. conjunctivitis, dry-eye disease).

- Current or past condition that might have caused corneal distortion or anterior
surface topography abnormalities (e.g. keratoconus, map-dot fingerprint or any other
corneal dystrophies, corneal disease or trauma resulting in scarring, pterygium,
pellucid marginal degeneration)

- Previous refractive corneal surgery (e.g., laser-assisted in situ keratomileusis
(LASIK), photorefractive keratectomy (PRK), corneal transplant, Descemet's Stripping
Endothelial Keratoplasty (DSEK) etc.).

- Considered by the Investigator to not be a suitable candidate for participation.